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UK MHRA Draft Guideline: Individualised mRNA Cancer Immunotherapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...
Sharan Murugan
Feb 52 min read
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USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
The USFDA Â continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...
Sharan Murugan
Nov 27, 20242 min read
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USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024)Â has issued two comprehensive Q&A guidance titled " Core...
Sharan Murugan
Oct 17, 20242 min read
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USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
Sharan Murugan
Apr 27, 20242 min read
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USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
Sharan Murugan
Nov 6, 20232 min read
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USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
Sharan Murugan
Dec 6, 20221 min read
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Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
Sharan Murugan
Aug 30, 20211 min read
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Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...
Sharan Murugan
Aug 8, 20211 min read
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